Results from the investigational, randomized, open-label IRAKLIA phase 3 study demonstrated that Sarclisa administered at a fixed dose subcutaneously (SC) via an on-body delivery system (OBDS) in combination with pomalidomide and dexamethasone (Pd) met its co-primary endpoints of non-inferior objective response rate (ORR) and observed concentration before dosing (C trough) at steady state compared to intravenous (IV) Sarclisa administered at a weight-based dose in combination with Pd in patients with relapsed or refractory multiple myeloma (R/R MM).

来自研究性，随机，开放标签的IRAKLIA 3期研究的结果表明，通过体内递送系统（OBDS）以固定剂量皮下（SC）联合pomalidomide和地塞米松（Pd）给药的Sarclisa符合其共同主要终点非劣效客观缓解率（ORR）和稳定状态下给药前观察到的浓度（C谷），而复发性或难治性多发性骨髓瘤（R/R MM）患者以基于体重的剂量联合Pd静脉注射（IV）Sarclisa。

Key secondary endpoints, including very good partial response (VGPR), incidence rate of infusion reactions and C trough at cycle 2 were also achieved. The study is ongoing, and the full results will be presented at a forthcoming medical meeting..

还实现了关键的次要终点，包括非常好的部分缓解（VGPR），输注反应的发生率和第2周期的C谷。这项研究正在进行中，完整的结果将在即将举行的医学会议上公布。。

Sikander Ailawadhi, MD

Sikander Ailawdhi，医学博士

Professor of Medicine, Division of Hematology/Oncology at Mayo Clinic Florida and principal investigator of the study

佛罗里达梅奥诊所血液学/肿瘤学系医学教授兼该研究的首席研究员

“The consistent overall response rate and comparable efficacy and safety profile observed in the IRAKLIA study for subcutaneous Sarclisa represent an exciting advancement, offering insight into a potential new administration option for patients. The results from IRAKLIA, in patients with relapsed or refractory multiple myeloma, support the potential of an on-body delivery system to help ease the delivery of a new formulation without impacting patient outcomes.”.

“IRAKLIA对皮下肌肉瘤的研究中观察到的一致的总体缓解率和可比的疗效和安全性代表了一个令人兴奋的进展，为患者提供了一种潜在的新给药选择的见解。IRAKLIA对复发或难治性多发性骨髓瘤患者的结果支持了体内递送系统的潜力，以帮助缓解新制剂的递送而不影响患者的预后。”。

The IRAKLIA study was conducted using Enable Injections’ enFuse®

IRAKLIA研究是使用Enable注射剂的enFuse进行的®

hands-free OBDS, which was designed to administer high-volume medicines subcutaneously through an automated drug delivery technology. The enFuse device leverages a hidden and retractable needle that is thinner compared to commonly used SC injection needles.

免提OBD，旨在通过自动药物输送技术皮下注射大量药物。enFuse设备利用了一种隐藏且可伸缩的针，与常用的SC注射针相比，它更薄。

Houman Ashrafian, MD, PhD

Houman Ashrafian，医学博士，哲学博士

Executive Vice President, Head of Research and Development at Sanofi

赛诺菲执行副总裁、研发主管

“We are fueled by our focus on innovation and finding best-in-class solutions to help ease the burden of disease for patients. The IRAKLIA study results are a prime example of what’s driving our scientific engine. Being able to possibly bring a novel option that helps reduce time in a healthcare facility is driven by our patient and provider-centric mindset.

“我们专注于创新，寻找一流的解决方案，以帮助减轻患者的疾病负担，这为我们提供了动力。IRAKLIA的研究结果是推动我们科学引擎的一个主要例子。我们以患者和提供者为中心的心态，推动了我们能够推出一种有助于减少医疗机构时间的新颖选择。

We look forward to sharing full results and working to bring this new advancement to the multiple myeloma community.”.

我们期待着分享全部成果，并努力为多发性骨髓瘤社区带来这一新进展。”。

Additional studies evaluating Sarclisa SC formulations across different combinations and lines of therapy are ongoing. The safety and efficacy of Sarclisa SC and the enFuse device have not been evaluated by any regulatory authority outside of their approved indications. Regulatory submissions in the US and in the EU are planned during the first half of 2025..

正在进行评估Sarclisa SC制剂在不同组合和治疗方案中的其他研究。Sarclisa SC和enFuse装置的安全性和有效性尚未由任何监管机构在其批准的适应症之外进行评估。美国和欧盟的监管提交计划在2025年上半年进行。。

About the IRAKLIA study

关于IRAKLIA研究

IRAKLIA is a randomized, open-label, pivotal phase 3 study evaluating the non-inferiority of Sarclisa SC formulation administered at a fixed dose subcutaneously via an OBDS versus weight-based dosed Sarclisa IV in combination with Pd in adult patients with R/R MM. The study enrolled 531 patients across 252 global sites, who were equally randomized to receive Sarclisa SC or IV in combination with Pd for 28-day cycles until disease progression, unacceptable adverse events (AEs), participant request to discontinue therapy or any other reason, whichever came first.

IRAKLIA是一项随机，开放标签，关键性的3期研究，评估了成年R/R MM患者通过OBDS皮下注射固定剂量的Sarclisa SC制剂与基于体重的剂量的Sarclisa IV联合Pd的非劣效性。该研究招募了252个全球站点的531名患者，他们同样随机接受Sarclisa SC或IV联合Pd治疗28天周期，直到疾病进展，不可接受的不良事件（AE），参与者要求停止治疗或任何其他原因，以先到者为准。

In the SC arm, Sarclisa was administered at a fixed dose SC weekly for four weeks during the first cycle and every two weeks for subsequent cycles. In the IV arm, Sarclisa was administered at a weight-based dose via IV infusion weekly for four weeks during the first cycle and every two weeks for subsequent cycles.

在SC组中，Sarclisa在第一个周期中每周以固定剂量SC给药四周，在随后的周期中每两周给药一次。在静脉注射组中，Sarclisa在第一个周期中每周通过静脉输注以基于体重的剂量给药四周，在随后的周期中每两周给药一次。

The study enrolled adult patients with MM who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor..

该研究招募了至少接受过一种治疗方案的成年MM患者，包括来那度胺和蛋白酶体抑制剂。。

The co-primary outcomes being assessed are ORR, defined as the proportion of patients with stringent complete response, complete response, VGPR, and partial response (PR) according to the 2016 IMWG criteria assessed by Independent Review Committee (IRC), and observed C trough at steady state, defined as observed Sarclisa plasma concentrations..

正在评估的共同主要结果是ORR，定义为根据独立审查委员会（IRC）评估的2016年IMWG标准，具有严格完全缓解，完全缓解，VGPR和部分缓解（PR）的患者比例，并观察到稳定状态下的C谷，定义为观察到的Sarclisa血浆浓度。。

About Enable Injections

关于启用注入

Based in the US (Cincinnati, Ohio), Enable Injections is a global healthcare innovation company committed to improving the patient treatment experience through the development and manufacturing of enFuse. enFuse is an innovative wearable drug delivery platform that is designed to deliver large volumes of pharmaceutical and biologic therapeutics via subcutaneous administration, with the aim of improving convenience, supporting superior outcomes, and advancing healthcare system economics.

Enable Injections总部位于美国（俄亥俄州辛辛那提），是一家全球医疗创新公司，致力于通过开发和制造enFuse来改善患者的治疗体验。enFuse是一种创新的可穿戴药物递送平台，旨在通过皮下给药提供大量药物和生物治疗剂，旨在提高便利性，支持优异的结果，并推进医疗系统的经济性。

About Sarclisa

关于Sarclisa

Sarclisa (isatuximab) is a CD38 monoclonal antibody that binds to a specific epitope on the CD38 receptor on MM cells, inducing distinct antitumor activity. It is designed to work through multiple mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on the surface of MM cells, making it a target for antibody-based therapeutics such as Sarclisa.

Sarclisa（isatuximab）是一种CD38单克隆抗体，可与MM细胞CD38受体上的特定表位结合，诱导独特的抗肿瘤活性。它旨在通过多种作用机制发挥作用，包括程序性肿瘤细胞死亡（凋亡）和免疫调节活性。CD38在MM细胞表面高度且均匀表达，使其成为基于抗体的治疗剂（如Sarclisa）的靶标。

In the US, the non-proprietary name for Sarclisa is isatuximab-irfc, with irfc as the suffix designated in accordance with nonproprietary naming of biological products guidance for industry issued by the US FDA..

在美国，Sarclisa的非专有名称是isatuximab irfc，irfc是根据美国FDA发布的《生物制品行业非专有命名指南》指定的后缀。。

Currently, Sarclisa is approved in more than 50 countries, including the US and EU, across two indications; Sarclisa is approved under an additional indication in the US. Based on the ICARIA-MM phase 3 study, Sarclisa is approved in combination with Pd for the treatment of patients with R/R MM who have received ≥2 prior therapies, including lenalidomide and a proteasome inhibitor, and who progressed on last therapy.

目前，Sarclisa在包括美国和欧盟在内的50多个国家获得了两种适应症的批准；根据ICARIA-MM 3期研究，Sarclisa被批准与Pd联合用于治疗先前接受过≥2次治疗的R/R MM患者，包括来那度胺和蛋白酶体抑制剂，以及最后一次治疗进展的患者。

Based on the IKEMA phase 3 study, Sarclisa is also approved in 50 countries in combination with carfilzomib and dexamethasone, including in the US for the treatment of patients with R/R MM who have received 1–3 prior lines of therapy and in the EU for patients with MM who have received at least 1 prior therapy.

根据IKEMA 3期研究，Sarclisa还被50个国家批准与卡非佐米和地塞米松联合使用，包括在美国用于治疗先前接受过1-3次治疗的R/R MM患者，在欧盟用于治疗至少接受过1次治疗的MM患者。

In the US, Sarclisa is approved in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a front-line treatment option for adult patients with newly diagnosed multiple myeloma (NDMM) who are not eligible for autologous stem cell transplant (ASCT), based on the IMROZ phase 3 study. On November 14, 2024, the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Sarclisa-VRd in this patient population.

在美国，Sarclisa被批准与硼替佐米，来那度胺和地塞米松（VRd）联合使用，作为成人新诊断多发性骨髓瘤（NDMM）患者的一线治疗选择，这些患者不符合自体干细胞移植（ASCT）的条件，基于IMROZ 3期研究。2024年11月14日，欧洲药品管理局（EMA）的人类使用药品委员会（CHMP）通过了一项积极的意见，建议在该患者人群中批准Sarclisa VRd。

A final decision is expected in the coming months..

预计未来几个月将做出最终决定。。

Sanofi continues to advance Sarclisa as part of a patient-centric clinical development program, which includes several phase 2 and phase 3 studies across the MM treatment continuum spanning six potential indications. Further clinical studies evaluating a subcutaneous administration method for Sarclisa are ongoing..

赛诺菲继续推进Sarclisa作为以患者为中心的临床开发计划的一部分，该计划包括跨越六个潜在适应症的MM治疗连续体的几项2期和3期研究。正在进行进一步的临床研究，评估Sarclisa的皮下给药方法。。

In striving to become the number one immunoscience company globally, Sanofi remains committed to advancing oncology innovation. Through focused strategic decisions the company has reshaped and prioritized its pipeline, leveraging its expertise in immunoscience to drive progress. Efforts are centered on difficult-to-treat often rare cancers such as select hematologic malignancies and solid tumors with critical unmet needs, including multiple myeloma, acute myeloid leukemia, certain types of lymphomas, as well as gastrointestinal and lung cancers..

在努力成为全球第一大免疫科学公司的过程中，赛诺菲仍然致力于推进肿瘤学创新。通过有针对性的战略决策，该公司重塑并优先考虑了其渠道，利用其在免疫科学方面的专业知识来推动进步。努力的重点是难以治疗的罕见癌症，如选择性血液恶性肿瘤和严重未满足需求的实体瘤，包括多发性骨髓瘤，急性髓细胞白血病，某些类型的淋巴瘤，以及胃肠道和肺癌。。

About Sanofi

关于赛诺菲

We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions..

我们是一家创新的全球医疗保健公司，其宗旨是：追求科学奇迹，改善人们的生活。我们在世界各地的团队致力于通过将不可能变为可能来改变医学实践。我们为全球数百万人提供潜在的改变生命的治疗方案和挽救生命的疫苗保护，同时将可持续性和社会责任作为我们雄心壮志的核心。。